Psychosis Clinical Trial
— SINAPPS2Official title:
A Randomised Phase II Double-blinded Placebo-controlled Trial of Intravenous Immunoglobulins and Rituximab in Patients With Antibody-associated Psychosis (SINAPPS2)
A randomised phase II double-blinded placebo-controlled trial designed to explore the utility of immunotherapy for patients with acute psychosis associated with anti-neuronal membranes (NMDA-receptor or Voltage Gated Potassium Channel). Primary objective: To test the efficacy of immunotherapy (IVIG and rituximab) for patients with acute psychosis associated with anti-neuronal membranes. Secondary objective: To test safety of immunotherapy (IVIG and rituximab) for patients with acute psychosis associated with anti-neuronal membranes.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | March 31, 2026 |
Est. primary completion date | March 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 70 Years |
Eligibility | Inclusion Criteria: - Acute psychosis >2 weeks. This may either be first episode or relapse after remission (remission defined as having mild or absent symptoms of psychosis for at least 6 months) - Serum or CSF neuronal membrane autoantibodies at pathological levels (including NMDAR, LGI1 and other) - Psychosis symptoms as defined by PANSS =4 on at least one of the following items: P1, P2, P3, N1, N4, N6, G5 and G9. Exclusion Criteria: - Current episode of psychosis greater than 24 months duration - Co-existing severe neurological disease - Evidence of current acute encephalopathy - Hepatitis or HIV infection, pregnancy - Contraindications to any trial drug - Concurrent enrolment in another CTIMP |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Cambridge University Hospitals NH Foundation Trust | Cambridge | |
United Kingdom | Royal Devon and Exeter NHS Foundation Trust | Exeter | |
United Kingdom | NHS Greater Glasgow and Clyde | Glasgow | |
United Kingdom | The Walton Centre NHS Foundation Trust | Liverpool | |
United Kingdom | King's College Hospital NHS Foundation Trust | London | |
United Kingdom | University College London Hospitals Nhs Foundation Trust | London | |
United Kingdom | Salford Royal NHS Foundation Trust | Manchester | |
United Kingdom | Nottingham University Hospitals NHS Trust | Nottingham | |
United Kingdom | Oxford University Hospitals NHS Foundation Trust | Oxford | |
United Kingdom | Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield |
Lead Sponsor | Collaborator |
---|---|
University of Cambridge | University of Oxford |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to start of symptomatic recovery (symptomatic remission sustained for at least 6 months) | remission defined as Positive and Negative Syndrome Scale (PANSS) score 3 or less on PANSS items P1, P2, P3, N1, N4, N6, G5 and G9 sustained for 6 months | up to 18 months | |
Secondary | Time to first treatment response (whether sustained or not) | Treatment response defined as score of 3 or less on each of the following PANSS items: P1, P2, P3, N1, N4, N6, G5, and G9. | up to 18 months | |
Secondary | Relapse rate | Relapse rate is defined as a score 4 or more on PANSS items P1, P2, P3, N1, N4, N6, G5, and G9. | 18 months | |
Secondary | Number of adverse effects | total number of patient reported adverse effects | 18 months | |
Secondary | Proportion of patients reaching 20% reduction in PANSS total score | 20% reduction in the PANSS total score (all PANNS items included) | 12 months | |
Secondary | Proportion of patients reaching 30% reduction in PANSS total score | 30% reduction in the PANSS total score (all PANNS items included) | 12 months | |
Secondary | Proportion of patients reaching 40% reduction in PANSS total score | 40% reduction in the PANSS total score (all PANNS items included) | 12 months | |
Secondary | Changes in the Clinical Global Impression Scale in Schizophrenia (CGI-Schizophrenia) | Change in CGI-Schizophrenia scores from baseline to month 12 | 12 months | |
Secondary | Changes in the Young Mania Rating Scale (YMRS) | Change in YMRS total score from baseline to month 12 | 12 months | |
Secondary | Changes in the Antipsychotic Non-Neurological Side-Effects Rating Scale (ANNSERS) | Change in ANNSERS total score from baseline to month 12 | 12 months | |
Secondary | Changes in the Brief Assessment of Cognition in Schizophrenia (BACS) | Change in BACS scores from baseline to month 12 | 12 months | |
Secondary | Changes in the Global Assessment of Functioning scale (GAF) | Change in the GAF score from baseline to month 12 | 12 months |
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